MAUDE Adverse Event Report: STRYKER TRAUMA KIEL GUIDE WIRE, BALL-TIPPED, STERILE T2 FEMUR Ø3X1000 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0085S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded.
Event or Problem Description
The customer reported that : "it has been noted that the guide wire has broken in its center during the operation, requiring extensive washing and creating an embolic risk.No clinical consequences have been reported.The incriminated device is not available for expertise since it has been thrown away.A mandatory report has been sent to the ansm.".
Event or Problem Description
The customer reported that : "it has been noted that the guide wire has broken in its center during the operation, requiring extensive washing and creating an embolic risk.No clinical consequences have been reported.The incriminated device is not available for expertise since it has been thrown away.A mandatory report has been sent to the ansm.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned, and no other evidence was provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on risk management file some of the possible causes of this failure are, but not limited to: strong bent in wire tip, cannulation clogged, etc.The instruction for use recommends to continuously check the position of k-wire tip with an image intensifier during insertion.It also recommends use of fluoroscopy whenever cannulated instruments are advanced over a k-wire and to always treat the instrument carefully to avoid surface damage or alterations to the geometry.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: GUIDE WIRE, BALL-TIPPED, STERILE T2 FEMUR Ø3X1000 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9987094
• Report Number: 0009610622-2020-00156
• Device Sequence Number: 4597160
• Product Code: LXH
• UDI-Device Identifier: 04546540195937
• UDI-Public: 04546540195937
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: 1806-0085S
• Device Catalogue Number: 18060085S
• Device Lot Number: K08A45A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2020
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 06/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1